A Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer (GPMOC202)

May 8, 2017 updated by: Samyang Biopharmaceuticals Corporation
The purpose of this study is to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Songpa-gu, Pungnap-2 Dong
      • Seoul, Songpa-gu, Pungnap-2 Dong, Korea, Republic of, 138-736
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Subjects who aged 18 years or older
  2. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
  3. Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.

Exclusion Criteria:

  1. Subjects who have received prior radiation therapy (XRT) for pancreatic cancer unless progression was documented after XRT and 6 weeks have elapsed between completion of XRT and start of trial medication.
  2. Subjects who have had systemic treatment such as chemotherapy or immunotherapy, for pancreatic cancer. However, prior use of chemotherapy, e.g. 5-FU or capecitabine, for radiation sensitization is allowed. If gemcitabine was given in the adjuvant setting, only subjects relapsed with cancer after 6 months of completing the last dose of gemcitabine can participate in the trial.
  3. Subjects who have had a major surgery within 2 weeks prior to the screening/baseline visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Genexol®-PM plus Carboplatin
Drug: Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC
Active Comparator: Genexol® plus Carboplatin
Drug: Genexol® 175mg/m2 plus Carboplatin 5 AUC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of Genexol®-PM plus Carboplatin versus Genexol® plus Carboplatin in subjects with ovarian cancer based on Composite Response Rate
Time Frame: up to 6 cycles
Proportion of subjects with CA125 and RECIST composite response rate was evaluated and compared between the groups. CA125 was evaluated among subjects without a measurable disease, while RECIST was evaluated among subjects with a measurable disease; discordance between the response rates by RECIST and CA125 were deemed as nonresponse.
up to 6 cycles

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: up to 3 years
The period from the date of first administration to the date of the patient's death
up to 3 years
Progression Free Survival
Time Frame: up to 3 years
The period from the date of first administration to the date of objective tumor progression by CA125 and RECIST or death
up to 3 years
Time to Progression
Time Frame: up to 3 years
The period from the date of first administration to the date of tumor progression by CA125 and RECIST or objective tumor progression, excluding progression-free death
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samyang Biopharmaceuticals Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 12, 2011

First Submitted That Met QC Criteria

January 12, 2011

First Posted (Estimate)

January 13, 2011

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPMOC202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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